Effects of Intravenous Injection of Erythropoietin on Hepcidin Pharmacokinetics in Healthy Volunteers (HEPEPO)

Rennes University Hospital

Status: Unknown

Conditions: Iron Metabolism Disorders

Treatments: Drug: Erythropoietin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00687518

CIC0203/056

DGS 2006/0416

Details and patient eligibility

About

The aim of this study is to measure the variations of serum and urinary hepcidin levels following a single intravenous injection of erythropoietin in healthy volunteers. Hepcidin is a major regulator of iron homeostasis. It acts by binding on ferroportin, and limits cellular efflux of iron through enterocytes and macrophages. Anemia and hypoxia are known to modulate hepcidin synthesis. In these situations, erythropoietin synthesis is increased, so it can be postulated that erythropoietin could modulate hepcidin synthesis.

Enrollment: 14 estimated patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy volunteers
• male aged 18 - 30
• normal routine laboratory values
• normal ECG
• normal iron status

Exclusion criteria

• C282Y mutation of the HFE gene
• alcohol or tobacco consumption

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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14 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

erythropoietin

Treatment:

Drug: Erythropoietin

2

Placebo Comparator group

Description:

Saline serum

Treatment:

Drug: Placebo